WO2011129579A3 - Oral pharmaceutical composition comprising fenofibric acid and an alkalifying agent - Google Patents

Oral pharmaceutical composition comprising fenofibric acid and an alkalifying agent Download PDF

Info

Publication number
WO2011129579A3
WO2011129579A3 PCT/KR2011/002560 KR2011002560W WO2011129579A3 WO 2011129579 A3 WO2011129579 A3 WO 2011129579A3 KR 2011002560 W KR2011002560 W KR 2011002560W WO 2011129579 A3 WO2011129579 A3 WO 2011129579A3
Authority
WO
WIPO (PCT)
Prior art keywords
fenofibric acid
pharmaceutical composition
oral pharmaceutical
alkalifying agent
weight
Prior art date
Application number
PCT/KR2011/002560
Other languages
French (fr)
Other versions
WO2011129579A2 (en
Inventor
Ki Young Jang
Mijin Park
Kyeong Soo Kim
Yong Il Kim
Jae Hyun Park
Jong Soo Woo
Original Assignee
Hanmi Holdings Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=44799154&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2011129579(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hanmi Holdings Co., Ltd. filed Critical Hanmi Holdings Co., Ltd.
Priority to US13/637,530 priority Critical patent/US20130022684A1/en
Priority to EP11769045.3A priority patent/EP2558077B1/en
Priority to ES11769045.3T priority patent/ES2626181T3/en
Priority to CN2011800184071A priority patent/CN102858325A/en
Priority to JP2013504813A priority patent/JP5685641B2/en
Publication of WO2011129579A2 publication Critical patent/WO2011129579A2/en
Publication of WO2011129579A3 publication Critical patent/WO2011129579A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics

Abstract

An oral pharmaceutical composition of the present invention comprising fenofibric acid or a pharmaceutically acceptable salt thereof, and 0.22 to 1 part by weight of an alkalifying agent based on 1 part by weight of fenofibric acid has improved bioavailability and a minimized absorption deviation in the gastrointestinal tract, which is useful in treating hyperlipidemia and hypertriglyceridemia.
PCT/KR2011/002560 2010-04-12 2011-04-12 Oral pharmaceutical composition comprising fenofibric acid and an alkalifying agent WO2011129579A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
US13/637,530 US20130022684A1 (en) 2010-04-12 2011-04-12 Oral pharmaceutical composition comprising fenofibric acid and an alkalifying agent
EP11769045.3A EP2558077B1 (en) 2010-04-12 2011-04-12 Oral pharmaceutical composition comprising fenofibric acid and an alkalifying agent
ES11769045.3T ES2626181T3 (en) 2010-04-12 2011-04-12 Oral pharmaceutical composition comprising fenofibric acid and an alkalizing agent
CN2011800184071A CN102858325A (en) 2010-04-12 2011-04-12 Oral pharmaceutical composition comprising fenofibric acid and an alkalifying agent
JP2013504813A JP5685641B2 (en) 2010-04-12 2011-04-12 Oral pharmaceutical composition comprising fenofibric acid and alkalizing agent

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2010-0033497 2010-04-12
KR1020100033497A KR101202994B1 (en) 2010-04-12 2010-04-12 Oral pharmaceutical composition comprising fenofibric acid and an alkalifying agent

Publications (2)

Publication Number Publication Date
WO2011129579A2 WO2011129579A2 (en) 2011-10-20
WO2011129579A3 true WO2011129579A3 (en) 2012-02-02

Family

ID=44799154

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2011/002560 WO2011129579A2 (en) 2010-04-12 2011-04-12 Oral pharmaceutical composition comprising fenofibric acid and an alkalifying agent

Country Status (7)

Country Link
US (1) US20130022684A1 (en)
EP (1) EP2558077B1 (en)
JP (1) JP5685641B2 (en)
KR (1) KR101202994B1 (en)
CN (1) CN102858325A (en)
ES (1) ES2626181T3 (en)
WO (1) WO2011129579A2 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2895827A1 (en) * 2012-12-21 2014-06-26 Merck Patent Gmbh Magnesium hydroxide carbonate as excipient in pharmaceutical preparations having improved release of active ingredient
CN103877064B (en) * 2014-04-11 2016-04-27 白玲强 A kind of fenofibrate micronized capsules agent and preparation technology thereof
KR20160148385A (en) 2015-06-16 2016-12-26 삼성전기주식회사 Wakeup detect circuit and electronic shelf label using the same
KR102081095B1 (en) 2018-04-24 2020-02-25 한국유나이티드제약 주식회사 Enteric coated formulation comprising fenofibric acid a or pharmaceutically acceptable salts thereof
KR102216579B1 (en) 2020-01-23 2021-02-17 한국유나이티드제약 주식회사 Enteric coated formulation comprising fenofibric acid a or pharmaceutically acceptable salts thereof
KR102501636B1 (en) * 2021-12-07 2023-02-21 에이스바이오팜 주식회사 Tablet for oral administration comprising fenofibric acid and method for manufacturing same

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4800079A (en) * 1986-08-08 1989-01-24 Ethypharm Sa Medicine based on fenofibrate, and a method of preparing it
US20010006662A1 (en) * 1999-05-29 2001-07-05 Steven L. Krill Novel formulations comprising lipid-regulating agents
US6531158B1 (en) * 2000-08-09 2003-03-11 Impax Laboratories, Inc. Drug delivery system for enhanced bioavailability of hydrophobic active ingredients
US20070071812A1 (en) * 1999-07-09 2007-03-29 Laboratoires Des Produits Ethiques Ethypharm Pharmaceutical composition containing fenofibrate and method for the preparation thereof
US20090035379A1 (en) * 1997-01-17 2009-02-05 Cabinet Hirsch Fenofibrate compositions
US20090263477A1 (en) * 2002-12-17 2009-10-22 Abbott Laboratories Salts of fenofibric acid and pharmaceutical formulations thereof

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US152714A (en) 1874-06-30 Improvement in gate-hinges
GB8607803D0 (en) 1986-03-27 1986-04-30 Kimberly Clark Ltd Non-woven laminated material
FR2627696B1 (en) 1988-02-26 1991-09-13 Fournier Innovation Synergie NEW GALENIC FORM OF FENOFIBRATE
DE4227385A1 (en) * 1992-08-19 1994-02-24 Kali Chemie Pharma Gmbh Pancreatin micropellets
US7259186B2 (en) 2002-12-17 2007-08-21 Abbott Laboratories Salts of fenofibric acid and pharmaceutical formulations thereof
US20070014846A1 (en) * 2003-10-10 2007-01-18 Lifecycle Pharma A/S Pharmaceutical compositions comprising fenofibrate and atorvastatin
US20070148233A1 (en) * 2005-12-28 2007-06-28 Lerner E I Pharmaceutical formulations of fenofibrate having improved bioavailability
EP1868587A2 (en) * 2005-04-08 2007-12-26 Abbott Laboratories Pharmaceutical formulations comprising fenofibric acid and/or its salts
US7915247B1 (en) * 2006-08-21 2011-03-29 Mutual Pharmaceutical Company, Inc. Methods of use of fenofibric acid
US20090162442A1 (en) * 2007-09-07 2009-06-25 Shenoy Dinesh B Multi-phasic, nano-structured compositions containing a combination of a fibrate and a statin

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4800079A (en) * 1986-08-08 1989-01-24 Ethypharm Sa Medicine based on fenofibrate, and a method of preparing it
US4961890A (en) * 1986-08-08 1990-10-09 Ethypharm Method of preparing comtrolled release fenofibrate
US20090035379A1 (en) * 1997-01-17 2009-02-05 Cabinet Hirsch Fenofibrate compositions
US20010006662A1 (en) * 1999-05-29 2001-07-05 Steven L. Krill Novel formulations comprising lipid-regulating agents
US20070071812A1 (en) * 1999-07-09 2007-03-29 Laboratoires Des Produits Ethiques Ethypharm Pharmaceutical composition containing fenofibrate and method for the preparation thereof
US6531158B1 (en) * 2000-08-09 2003-03-11 Impax Laboratories, Inc. Drug delivery system for enhanced bioavailability of hydrophobic active ingredients
US20090263477A1 (en) * 2002-12-17 2009-10-22 Abbott Laboratories Salts of fenofibric acid and pharmaceutical formulations thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP2558077A4 *

Also Published As

Publication number Publication date
CN102858325A (en) 2013-01-02
ES2626181T3 (en) 2017-07-24
EP2558077B1 (en) 2017-03-01
KR101202994B1 (en) 2012-11-21
JP5685641B2 (en) 2015-03-18
US20130022684A1 (en) 2013-01-24
KR20110114073A (en) 2011-10-19
EP2558077A4 (en) 2014-01-01
WO2011129579A2 (en) 2011-10-20
EP2558077A2 (en) 2013-02-20
JP2013523878A (en) 2013-06-17

Similar Documents

Publication Publication Date Title
EP2749284A3 (en) Combination of glycopyrronium and carmoterol
WO2011012816A3 (en) Pharmaceutical formulation
WO2011129579A3 (en) Oral pharmaceutical composition comprising fenofibric acid and an alkalifying agent
EP2340821A4 (en) Prophylactic/ameliorating agent for adult diseases comprising 5-aminolevulinic acid, derivative of 5-aminolevulinic acid, or salt of 5-aminolevulinic acid or the derivative of 5-aminolevulinic acid as active ingredient
IL224544B (en) Compound useful for the treatment of nonsense-mutation-mediated diseases and pharmaceutical composition comprising said compound
IL224215A (en) Combination pharmaceutical composition for treating functional diseases or conditions of the gastrointestinal tract
WO2011093826A3 (en) Effervescent formulations comprising cefaclor and clavulanic acid as active agents
IL217052A0 (en) Nanostructured sildenafil base, its pharmaceutically acceptable salts and co-crystals, compositions of them, process for the preparation thereof and pharmaceutical compositions containing them
WO2011014825A3 (en) Antiangiogenic small molecules and methods of use
WO2010129057A8 (en) Tetracycline compounds
EP2588106A4 (en) Sustained-release pharmaceutical composition containing pramipexole or pharmaceutically acceptable salt thereof with improved stability
WO2011152804A3 (en) Process for dry powder formulations
WO2014036502A3 (en) Tetracycline compounds
IL232384A (en) Use of the compounds halofenate or halofenic acid for the preparation of medicaments for treatment of gout
WO2010132670A3 (en) Pentacycline compounds
WO2011089126A3 (en) Novel retigabine composition
WO2010012459A3 (en) A process for the preparation of solifenacin salts and their inclusion into pharmaceutical dosage forms
WO2011142731A3 (en) Formulations comprising a third generation cephalosporin and clavulanic acid
WO2012074830A3 (en) Modified release tranexamic acid formulation
WO2011093818A3 (en) Pharmaceutical compositions comprising salmeterol and fluticasone
HU1000565D0 (en) Process for the preparation of pharmaceutically active compound and intermediers
WO2009011901A3 (en) Methods for promoting wakefulness
HK1183488A1 (en) Process for the synthesis of ivabradine and addition salts thereof with a pharmaceutically acceptable acid
HU1000299D0 (en) Nanostructured atorvastatin, its pharmaceutically acceptable salts and pharmaceutical compositions containing them and process for their preparation
EP2452678A3 (en) Pulsatile-release pharmaceutical formulation of dexlansoprazole

Legal Events

Date Code Title Description
WWE Wipo information: entry into national phase

Ref document number: 201180018407.1

Country of ref document: CN

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 11769045

Country of ref document: EP

Kind code of ref document: A2

REEP Request for entry into the european phase

Ref document number: 2011769045

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 2011769045

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 13637530

Country of ref document: US

ENP Entry into the national phase

Ref document number: 2013504813

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE